Label: IBUPROFEN- ibuprofen capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/12

If you are a consumer or patient please visit this version.

  • Active ingredient (in each capsule)

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

    (present as the free acid and potassium salt)
    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever/ fever reducer

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  • Uses

    • temporarily relieves minor aches and pains due to:
    • headache
    • backache
    • the common cold
    • minor pain of arthritis
    • temporarily reduces fever
    • toothache
    • menstrual cramps
    • muscular aches
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  • Warnings

    Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
    • skin reddening
    • rash
    • blisters

    If an allergic reaction occurs, stop use and seek medical help right away

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have problems or serious side effects from taking pain relievers or fever reducers
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
    • you are taking a diuretic

    Ask a doctor or pharmacist before use if you are

    • under a doctor's care for any serious condition
    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • taking any other drug

    When using this product

    • take with food or milk if stomach upset occurs
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear

    If pregnant or breast- feeding,

    ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery

    Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 capsule, 2 capsules may be used
    • do not exceed 6 capsules in 24 hours, unless directed by a doctor
    • children under 12 years: ask a doctor
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  • Other information

    • each capsule contains: potassium 20 mg
    • read all warnings and directions before use.
    • store at 20° to 25°C (68° to 77°F)
    • avoid excessive heat above 40°C (104°F).
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  • Inactive ingredients

    FD&C blue #1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol

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  • Questions or Comments ?

    Call toll free 1-800-632-6900

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  • Principal Display Panel

    Compare to the active ingredient in Advil® Liqui- Gels® †See bottom panel

    Important: Read all product information before using

    EASY OPEN CAP

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    Ibuprofen Capsules 200 mg

    Pain reliever/ fever reducer (NSAID)

    160 CAPSULES**

    soft gelatin capsules**

    **(Liquid filled capsules)

    †Advil® is a registered trademark of pfizer consumer healthcare, Madison, NJ 07940. Pfizer consumer healthcare is not affiliated with the Kroger co. or this product

    DISTRIBUTED BY THE KROGER CO.

    CINCINNATI, OHIO 45202

    Do not use if seal under cap imprinted with "SEALED FOR YOUR PROTECTION" is broken or missing.

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  • Product Label

    kroger Ibuprofen softgels 160 count

    Ibuprofen capsules 200 mg

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  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-123
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1  
    GELATIN  
    POLYETHYLENE GLYCOLS  
    POTASSIUM HYDROXIDE  
    WATER  
    SORBITOL  
    Product Characteristics
    Color BLUE Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code A356
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-123-16 1 in 1 BOX
    1 160 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA202300 07/12/2012
    Labeler - The Kroger Co. (006999528)
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